Quality Engineer
Job Type
Full-time
Description

SetPoint Medical is seeking an experienced quality engineer to work collaboratively in a cross-functional environment to ensure the delivery of high-quality development projects within approved program schedules. The Quality Engineer will be responsible for the generation and/or review of design verification/validation testing as well as process validations at component and contract manufacturers.


All candidates will be asked to describe in detail their individual as well as team contributions towards development and testing activities within a Class II/III medical device environment.

Requirements

Job Responsibilities

  • Provide input during project planning to accurately assess resource and scheduling considerations
  • Partner with Product Development, Manufacturing Engineering and other cross-functional team members to refine requirements
  • Review and approve design input and design output documentation
  • Partner with Product Development, Manufacturing Engineering and other cross-functional team members and consultants/external test houses to define verification and validation testing plans
  • Assist in the execution of characterization studies, dry runs and in oversight of official V&V testing
  • Review and approve verification and validation test plans and test reports
  • Represent as quality assurance team member in design reviews meetings
  • Provide input into system level risk management deliverables (i.e. plans, Device Hazard Analyses, reports, and Risk Management File)
  • Develop and/or approve project risk management deliverables (i.e. dFMEA, pFMEA, uFMEA)
  • Review and assess assigned proposed changes (i.e. Change Orders, Special Rework Instructions) to ensure proper level of testing supports implementation
  • Verify program documentation is in compliance with company procedures
  • Current working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and other standards as required
  • Other projects as assigned

Minimum Qualifications

  • Bachelor's degree in Engineering, related technology, or equivalent experience required; MS preferred
  • Medical device industry experience preferred
  • Experience with Class III sterile, implantable electromechanical devices utilizing microcontrollers strongly preferred
  • Demonstrated individual and team-based contributions towards development and testing activities
  • GD&T skills and knowledge is desirable
  • Quality System Knowledge including 21 CFR 820, ISO 13485, and ISO 14971
  • Demonstrated skills in statistical analysis

Required Skills and Abilities

  • Work collaboratively and effectively on cross-functional teams to meet program goals
  • Ability to effectively support multiple high priority deliverables at once
  • Outstanding written and oral communication skills
  • High attention to detail
  • Ability to review, analyze, summarize, and interpret data to draw conclusions and make appropriate recommendations and decisions
  • Must be able to write clear, understandable reports, and give oral presentations
  • Strong organizational and time management skills
  • Ability to take a creative and proactive approach when considering resolutions and/or alternatives
  • Effective interpersonal/communication skills

Company Description

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.


Relocation

Not available


Salary Range: $85,000 - $125,000, depending on experience


Location

Company Headquarters in Valencia, CA